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Importance: Vacuum aspiration is commonly used to remove retained products of conception in patients with incomplete spontaneous abortion. Scarring of the uterine cavity may occur, potentially impairing future fertility. A procedural alternative, operative hysteroscopy, has gained popularity with a presumption of better future fertility. Objective: To assess the superiority of hysteroscopy to vacuum aspiration for subsequent pregnancy in patients with incomplete spontaneous abortion who intend to have future pregnancy. Design, Setting, and Participants: The HY-PER randomized, controlled, single-blind trial included 574 patients between November 6, 2014, and May 3, 2017, with a 2-year duration of follow-up. This multicenter trial recruited patients in 15 French hospitals. Individuals aged 18 to 44 years and planned for surgery for an incomplete spontaneous abortion with plans to subsequently conceive were randomized in a 1:1 ratio. Interventions: Surgical treatment by hysteroscopy (n = 288) or vacuum aspiration (n = 286). Main Outcomes and Measures: The primary outcome was a pregnancy of at least 22 weeks' duration during 2-year follow-up. Results: The intention-to-treat analyses included 563 women (mean [SD] age, 32.6 [5.4] years). All aspiration procedures were completed. The hysteroscopic procedure could not be completed for 19 patients (7%), 18 of which were converted to vacuum aspiration (8 with inability to completely resect, 7 with insufficient visualization, 2 with anesthetic complications that required a shortened procedure, 1 with equipment failure). One hysteroscopy failed due to a false passage during cervical dilatation. During the 2-year follow-up, 177 patients (62.8%) in the hysteroscopy group and 190 (67.6%) in the vacuum aspiration (control) group achieved the primary outcome (difference, -4.8% [95% CI, -13% to 3.0%]; P = .23). The time-to-event analyses showed no statistically significant difference between groups for the primary outcome (hazard ratio, 0.87 [95% CI, 0.71 to 1.07]). Duration of surgery and hospitalization were significantly longer for hysteroscopy. Rates of new miscarriages, ectopic pregnancies, Clavien-Dindo surgical complications of grade 3 or above (requiring surgical, endoscopic, or radiological intervention or life-threatening event or death), and reinterventions to remove remaining products of conception did not differ between groups. Conclusions and Relevance: Surgical management by hysteroscopy of incomplete spontaneous abortions in patients intending to conceive again was not associated with more subsequent births or a better safety profile than vacuum aspiration. Moreover, operative hysteroscopy was not feasible in all cases. Trial Registration: ClinicalTrials.gov Identifier: NCT02201732.
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Aborto Espontáneo , Embarazo Ectópico , Embarazo , Humanos , Femenino , Adulto , Legrado por Aspiración , Método Simple Ciego , HisteroscopíaRESUMEN
STUDY OBJECTIVE: To evaluate fertility, pregnancy, and clinical outcomes after uterine arteriovenous malformation (UAVM) management. DESIGN: Single-center retrospective study (Canadian Task Force classification III). SETTING: One referral center. PATIENTS: Twenty-two patients with a UAVM diagnosed by magnetic resonance angiography or computed tomography angiography and managed by expectant management (EM) or uterine arterial embolization (UAE) during the study period were included. INTERVENTIONS: Nine of 22 patients underwent first-intention EM and 13 first-line UAE. Three of 9 EM patients (33.3%) required emergency second-intention UAE for nonresolution of the UAVM and severe genital bleeding. MEASUREMENTS AND MAIN RESULTS: To analyze fertility according to management approach, we defined 2 groups: EM only group (nâ¯=â¯6) and UAE group (nâ¯=â¯16; women who underwent first- or second-intention UAE). Overall, the median age was 29 years (range, 17-43). The mean follow-up after UAVM management was 39 months (range, 1-116). The success rate of the UAE procedure was 87.5% (14/16). Eight of 12 women (66.7%) who wished to conceive became pregnant: 2 of 5 (33.3%) in the EM group and 6 of 7 (85.7%) in the UAE group (pâ¯=â¯1). Overall, 11 patients (50%) conceived: 3 in the EM group (50%) and 8 in the UAE group (50%) (pâ¯=â¯.9). The live birth rate was 36.4% (8/22) for the whole population. There were no miscarriages or ectopic pregnancies. The 8 women (72.7%) wishing to conceive who became pregnant all delivered: 1 by cesarean section and 7 by vaginal delivery. Median duration of pregnancy was 39 weeks and 5 days. The remaining 3 women (i.e., women who conceived but did not wish to become pregnant) had therapeutic abortions. One complication was experienced in the EM group (small for gestational age newborn) and none in the UAE group (pâ¯=â¯.3). Limitations include retrospective design and small sample size. CONCLUSION: UAE for UAVM is an effective and safe technique. It does not impair fertility, and obstetric prognosis is good.
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Malformaciones Arteriovenosas/cirugía , Embarazo Ectópico/cirugía , Embolización de la Arteria Uterina/métodos , Útero/irrigación sanguínea , Adolescente , Adulto , Malformaciones Arteriovenosas/diagnóstico por imagen , Cesárea/efectos adversos , Angiografía por Tomografía Computarizada , Femenino , Fertilidad , Humanos , Angiografía por Resonancia Magnética , Embarazo , Resultado del Embarazo , Estudios Retrospectivos , Ultrasonografía Doppler , Anomalías Urogenitales/diagnóstico por imagen , Útero/anomalías , Útero/diagnóstico por imagen , Adulto JovenRESUMEN
Epithelial ovarian cancer (EOC) usually spreads into the peritoneal cavity, thereby providing an opportunity for intraperitoneal adoptive immunotherapy with Vγ9Vδ2 T lymphocytes, a T cell subpopulation endowed with high lytic properties against tumor cells. However, previous studies have reported that Vγ9Vδ2 T cells fail to expand from peripheral blood mononuclear cells in one-third of patients with cancer. Here, from a cohort of 37 patients with EOC, a multiple correspondence analysis identified three populations, one of which was not suitable for Vγ9Vδ2 T-cell adoptive therapy. Interestingly, the ineligible patients were identified based on the frequency of Vγ9Vδ2 T cells in their peripheral blood and the patients' age. The average time to tumor recurrence was also found to be significantly different between the three populations, suggesting that the innate immune response is involved in EOC prognosis. A dramatic decrease in the lytic properties of Vγ9Vδ2 T cells occurred following incubation with ascitic supernatant and was found to be associated with reduced perforin/granzyme degranulation. Prostaglandin E2, but not IL-6, IL-10, VEGF or TGF-ß, showed immunosuppressive effects in Vγ9Vδ2 T cells. Interestingly, our results emphasize that pretreating ovarian tumor cells with zoledronate partially reverses the immunosuppressive effects of ovarian cancer-associated ascites and restores a high level of lytic activity. These data sustain that optimal Vγ9Vδ2 T-cell adoptive immunotherapy previously requires counteracting the tumor immunosuppressive microenvironment. Altogether, our findings provide a rationale for clinically evaluating Vγ9Vδ2 T-cell adoptive immunotherapy with intraperitoneal carcinomatosis presensitization by zoledronate in patients with EOC.
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Dinoprostona/fisiología , Difosfonatos/farmacología , Imidazoles/farmacología , Inmunoterapia , Neoplasias Ováricas/patología , Linfocitos T Citotóxicos/inmunología , Adulto , Anciano , Anciano de 80 o más Años , Anticuerpos Monoclonales/inmunología , Anticuerpos Monoclonales/uso terapéutico , Ascitis/fisiopatología , Línea Celular Tumoral , Femenino , Citometría de Flujo , Humanos , Persona de Mediana Edad , Neoplasias Ováricas/terapia , Ácido ZoledrónicoRESUMEN
OBJECTIVE: To assess the prevalence of Chlamydia trachomatis (CT) infection and the risk factors for CT infection among women presenting for abortion at a clinic in France. METHODS: Women seeking surgically induced abortions were systematically screened by PCR on self-collected vaginal swabs between January 1, 2010, and September 30, 2010. CT-positive women were treated with oral azithromycin (1 g) before the surgical procedure. RESULTS: Of the 978 women included in the study, 66 were CT positive. The prevalence was 6.7% (95% confidence intervals [CI] 5.1%-8.3%). The risk factors for CT infection were the following: age <30 years (Odds ratio [OR]: 2.0 [95% CI: 1.2-3.5]), a relationship status of single (OR: 2.2 [95% CI: 1.2-4.0]), having 0 or 1 child (OR: 5.2 [95% CI: 2.0-13.0]), not using contraception (OR: 2.4 [95% CI: 1.4-4.1]), and completing 11 weeks or more of gestation (OR: 2.1 [95% CI: 1.3-3.6]). Multiple logistic regression indicated that 4 factors--having 0 or 1 child, a single relationship status, no contraceptive use, and a gestation of 11 weeks or more--were independently associated with CT infection. The rate of postabortion infection among all patients was 0.4% (4/978). CONCLUSIONS: These results reveal a high prevalence (6.7%) of CT-positive patients among French women seeking induced abortions. Because it is not common practice to screen the general population for CT, screening before induced abortions seems relevant. A cost-effectiveness study is required to evaluate this screen-and-treat policy.
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Aborto Inducido/estadística & datos numéricos , Antibacterianos/administración & dosificación , Azitromicina/administración & dosificación , Infecciones por Chlamydia/epidemiología , Chlamydia trachomatis/aislamiento & purificación , Tamizaje Masivo , Adulto , Infecciones por Chlamydia/diagnóstico , Infecciones por Chlamydia/tratamiento farmacológico , Femenino , Francia/epidemiología , Política de Salud , Humanos , Embarazo , Prevalencia , Derivación y Consulta , Estudios Retrospectivos , Vigilancia de Guardia , Factores de TiempoRESUMEN
INTRODUCTION: Endometriosis is a chronic inflammatory disease with a negative impact on fertility. The Enzian classification provides a precise description of deep pelvic endometriotic lesions, especially in the retroperitoneal area, from preoperative pelvic MRI scans. However, it is not known if it is correlated with postoperative fertility. STUDY OBJECTIVE: To determine if there is an association between the preoperative Enzian score and postoperative fertility after deep pelvic endometriosis surgery. DESIGN: We conducted a descriptive, retrospective study using information from the ENDOREN database. SETTING: This was a retrospective study at the Department of Obstetrics and Gynecology at Rennes University Hospital (France) from January 2013 to May 2019 PATIENTS AND INTERVENTIONS: We used information from the ENDOREN database that included all women who underwent surgery for deep endometriosis and wish to conceive. This surgery was intended in a view to achieve a complete removal of endometriosis. MEASUREMENTS: The Enzian score was calculated from preoperative MRI scans, and total, spontaneous, and after In Vitro fertilization (IVF) live births and pregnancies outcomes were collected from the patients'computerized medical records. Univariate and multivariate analysis was performed. RESULTS: Sixty-eight patients were included. The live-birth rate was 35% (24/68). According to the Enzian classification, 25 patients (35%) were classified in compartment A, 64 patients (94%) in compartment B, and 27 (40%) in compartment C. In multivariate analysis, positive predictor of live birth was single Enzian B score (OR=4.7[1.21; 18.81], p = 0.03), negative predictors were uterine adenomyosis and a history of endometriosis surgery. In multivariate analysis, positive predictor of spontaneous live birth was EFI score ≥7 (OR =22.434; CI [1.138; 442.190]). In multivariate analysis, positive predictor was Enzian A score (OR=15.9[2.2; 114.7], p = 0.006), and negative predictors was uterine adenomyosis and Enzian B score (OR=0.01[0; 0.495], p = 0.02) for live birth after IVF. CONCLUSION: The present retrospective study cannot strongly conclude about fertility and correlation with Enzian score because the groups are too small. However, it seems that when solely the compartment B is involved by endometriosis, complete full removal of endometriosis leads to better post-operative live births results. Other studies must be done to determine if Enzian classification based on preoperative pelvic MRI could be clinical value in the decision-making strategy for managing infertile patients with deep pelvic endometriosis.
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Adenomiosis , Endometriosis , Femenino , Fertilidad , Humanos , Pelvis , Embarazo , Estudios RetrospectivosRESUMEN
BACKGROUND: The aim of this study was to estimate the fertility and pregnancy outcomes after successful conservative treatment for placenta accreta. METHODS: This retrospective national multicenter study included women with a history of conservative management for placenta accreta in French university hospitals from 1993 through 2007. Success of conservative treatment was defined by uterine preservation. Data were retrieved from medical files and telephone interviews. RESULTS: Follow-up data were available for 96 (73.3%) of the 131 women included in the study. There were eight women who had severe intrauterine synechiae and were amenorrheic. Of the 27 women who wanted more children, 3 women were attempting to become pregnant (mean duration: 11.7 months, range: 7-14 months), and 24 (88.9% [95% confidence interval (CI), 70.8-97.6%]) women had had 34 pregnancies (21 third-trimester deliveries, 1 ectopic pregnancy, 2 elective abortions and 10 miscarriages) with a mean time to conception of 17.3 months (range, 2-48 months). All 21 deliveries had resulted in healthy babies born after 34 weeks of gestation. Placenta accreta recurred in 6 of 21 cases [28.6% (95% CI, 11.3-52.2%)] and was associated with placenta previa in 4 cases. Post-partum hemorrhage occurred in four [19.0% (95% CI, 5.4-41.9%)] cases, related to placenta accreta in three and to uterine atony in one. CONCLUSIONS: Successful conservative treatment for placenta accreta does not appear to compromise the patients' subsequent fertility or obstetrical outcome. Nevertheless, patients should be advised of the high risk that placenta accreta may recur during future pregnancies.
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Fertilidad , Placenta Accreta/terapia , Resultado del Embarazo , Adulto , Femenino , Ginatresia/etiología , Humanos , Hemorragia Posparto/etiología , Hemorragia Posparto/cirugía , Embarazo , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
OBJECTIVE: To describe symptoms and fertility and quality of life outcomes after isthmocele surgery. STUDY DESIGN: We conducted a retrospective study on from January 2012 to December 2017 in two tertiary referral centers in Rennes (France). All the patients diagnosed with isthmocele and operated were included. They all underwent isthmocele surgery by hysteroscopy, vaginal way or laparotomy. RESULTS: The following data were collected: surgical procedure, symptoms and fertility before and after surgery, patient satisfaction about the surgery, and quality of life after surgery. Eighteen patients were included. The mean duration of follow-up was 15 months. Surgical procedures consisted of hysteroscopy (n = 5/18, 27.8%), vaginal surgery (n = 8/18, 44.4%) and laparotomy (n = 5/18, 27.8%). Surgical indications were: secondary infertility (n = 10/18, 55 %), pelvic pain (n = 5/18, 28%) and abnormal uterine bleeding (n = 3/18, 17%). Among patients with abnormal uterine bleeding, improvement was obtained after hysteroscopy, laparotomy and vaginal surgery for 83.3%, 75% and 50%, respectively. Among those with pelvic pain, improvement was obtained after hysteroscopy, laparotomy and vaginal surgery for 80%, 81% and 66%, respectively. One patient (1/18, 5.5%) had post-operative complication. Of the 12 patients who wished to conceive eleven pregnancies were obtained (91.7%). Of the 10 patients with secondary infertility, six became pregnant (60%). Five pregnancies (5/11, 45.4%) were carried to full term, including four in patients whose surgical indication was infertility. Among these, one patient had a vaginal delivery (after vaginal surgery) without obstetric complication. All patients operated on by hysteroscopy would recommend this surgery versus 75% of patients with vaginal surgery and 60% of patients with laparotomy (p = 0.24). Pain and quality-of-life scores were comparable between the three groups. CONCLUSION: Isthmocele surgery is effective for abnormal uterine bleeding, pain and infertility regardless of the surgical route.
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Cesárea/efectos adversos , Cicatriz/cirugía , Histeroscopía/estadística & datos numéricos , Laparotomía/estadística & datos numéricos , Adulto , Cicatriz/etiología , Femenino , Fertilidad , Humanos , Persona de Mediana Edad , Satisfacción del Paciente/estadística & datos numéricos , Embarazo , Resultado del Embarazo , Estudios RetrospectivosRESUMEN
OBJECTIVE: To assess the effectiveness of conservative treatment for the management of non-tubal ectopic pregnancies (NTEP) METHODS: Retrospective cohort study in three centers (two referral centers) of patients managed for NTEP diagnosed by 2D or 3D ultrasonograhy. Patients underwent one of the following: expectant management, systemic methotrexate (MTX) injection, local MTX injection, combined MTX injection (local and systemic), local injection of hyperosmolar glucose, or misoprostol administration. The primary endpoint was final success defined by resolution of hCG level without need for emergency surgical treatment. Sixty-four patients diagnosed with NTEP were included: 37 (57%) had an interstitial pregnancy, 23 (35.9%) a cesarean scar pregnancy, two (3.1%) a cervical pregnancy and two (3.1%) an ovarian pregnancy. RESULTS: Six patients (9.4%) underwent expectant management, 24 (37.5%) a systemic MTX injection, 28 (43.8%) a local injection of MTX, three (4.7%) a combined MTX injection, one (1.6%) a local injection of hyperosmolar glucose (1.6%), and two (3.1%) were administered misoprostol. The median age was 32 years (22-45) and mean follow-up was 41 months. The final success rate overall was 92.2%: 100% for expectant management, 87.5% for systemic MTX, 96.4% for local MTX, 100% for combined injection of MTX, 100% for local injection of hyperosmolar glucose, and 50% for misoprostol. No patient required a hysterectomy. Nine (14.1%) patients required surgery, including five (7.8% (5/64)) following a rupture of the NTEP. CONCLUSIONS: Our results suggest that conservative medical management of NTEP is effective and safe and should be the first-line treatment for pauci-symptomatic patients with an NTEP.
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OBJECTIVE: To define and assess the prevalence of potentially life-threatening gynecologic emergencies among women presenting for acute pelvic pain for the purpose of developing measures to audit quality of care in emergency departments. METHODS: We conducted a mixed-methods multicenter study at gynecologic emergency departments in France and Belgium. A modified Delphi procedure was first conducted in 2014 among health care professionals to define relevant combinations of potentially life-threatening conditions and near misses in the field of gynecologic emergency care. A prospective case-cohort study in the spring of 2015 then assessed the prevalence of these potentially life-threatening emergencies and near misses among women of reproductive age presenting for acute pelvic pain. Women in the case group were identified at 21 participating centers. The control group consisted of a sample of women hospitalized for acute pelvic pain not caused by a potentially life-threatening condition and a 10% random sample of outpatients. RESULTS: Eight gynecologic emergencies and 17 criteria for near misses were identified using the Delphi procedure. Among the 3,825 women who presented for acute pelvic pain, 130 (3%) were considered to have a potentially life-threatening condition. The most common diagnoses were ectopic pregnancies with severe bleeding (n=54; 42%), complex pelvic inflammatory disease (n=30; 23%), adnexal torsion (n=20; 15%), hemorrhagic miscarriage (n=15; 12%), and severe appendicitis (n=6; 5%). The control group comprised 225 hospitalized women and 381 outpatients. Diagnostic errors occurred more frequently among women with potentially life-threatening emergencies than among either hospitalized (odds ratio [OR] 1.7, 95% CI 1.1-2.7) or outpatient (OR 14.7, 95% CI 8.1-26.8) women in the control group. Of the women with potentially life-threatening conditions, 26 met near-miss criteria compared with six with not potentially life-threatening conditions (OR 25.6, 95% CI 10.9-70.7). CONCLUSIONS: Potentially life-threatening gynecologic emergencies are high-risk conditions that may serve as a useful framework to improve quality and safety in emergency care.
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Servicio de Urgencia en Hospital/estadística & datos numéricos , Ginecología/estadística & datos numéricos , Potencial Evento Adverso/estadística & datos numéricos , Dolor Pélvico/terapia , Indicadores de Calidad de la Atención de Salud/estadística & datos numéricos , Adulto , Bélgica/epidemiología , Estudios de Casos y Controles , Técnica Delphi , Urgencias Médicas , Servicio de Urgencia en Hospital/normas , Femenino , Francia/epidemiología , Ginecología/normas , Humanos , Potencial Evento Adverso/normas , Dolor Pélvico/epidemiología , Estudios Prospectivos , Garantía de la Calidad de Atención de Salud , Mejoramiento de la Calidad , Indicadores de Calidad de la Atención de Salud/normasRESUMEN
OBJECTIVE: To assess the diagnostic performance of the NG-Test human chorionic gonadotropin (hCG) WB, which is a new point-of-care (POC) hCG whole-blood test. MATERIALS AND METHODS: This prospective study included women consulted in early pregnancy units for vaginal bleeding and/or pelvic pain with unknown pregnancy status after medical consultation including a pelvic ultrasound scan. A new POC test (the NG-Test hCG WB) and the usual laboratory serum test (considered the gold standard) were performed in patients. The results were interpreted in a blinded manner. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for the NG-Test hCG WB. RESULTS: During the study period, 200 patients were included. The pregnancy rate was 17%. For the laboratory test, with a 5 UI/l hCG positivity threshold, the sensitivity, specificity, PPV, NPV, and Youden index of the NG-Test hCG WB were 89.7, 100, 100, 97.9, and 0.90%, respectively. Considering a 10 UI/l hCG positivity threshold, test sensitivity, specificity, PPV, NPV, and Youden index were 96.3, 100, 100, 99.3, and 0.96%, respectively. False-negative cases were either extremely brief pregnancies or residual hCG after miscarriage. The result was obtained within 5 min with the NG-Test hCG WB versus 90±31 min with the laboratory test. It was easy to use. CONCLUSION: The NG-Test hCG WB showed a high sensitivity, specificity, PPV, and NPV. Its use as triage in the case of a negative pelvic ultrasound exam is a potential strategy to improve patient flow, with an average time saving of 85 min.
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Gonadotropina Coriónica/sangre , Diagnóstico Precoz , Pruebas de Embarazo/normas , Progesterona/sangre , Adulto , Femenino , Humanos , Valor Predictivo de las Pruebas , Embarazo , Primer Trimestre del Embarazo , Estudios Prospectivos , Sensibilidad y Especificidad , Adulto JovenRESUMEN
A case of diffuse-adenomatoid tumor of the uterus occurring in a 43-year-old patient with a renal-allograft transplant is reported. Grossly, the lesions were thought to be multiple leiomyomas. The diagnosis was supported by the adenomatoid and angiomatoid histologic patterns and the mesothelial immunophenotype. Diffuse-adenomatoid tumor of the uterus is a rare and benign lesion, usually reported in patients with immunodeficiency and renal transplant.
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Adenoma/patología , Trasplante de Riñón/patología , Neoplasias Uterinas/patología , Adulto , Calbindina 2 , Eosinófilos/patología , Femenino , Humanos , Leiomioma/patología , Músculo Liso/patología , Proteína G de Unión al Calcio S100/análisisRESUMEN
OBJECTIVE: To assess the value of serial hCG and progesterone serum level in the diagnosis of early pregnancy viability. METHODS: It was a prospective cohort study. Women with a pregnancy of uncertain viability (PUV), defined as the presence of an intra-uterine embryo with a crown-rump length <7mm with no cardiac activity or an intra-uterine gestational sac size <25mm with no visible embryonic structure in a transvaginal ultrasound scan (TVS) were eligible. The diagnosis value of serial plasmatic hCG levels on the first day and 48h after as well as the initial progesterone level were evaluated to diagnose pregnancy viability. Pregnancy viability was assessed by TVS 7 to 14days after inclusion. RESULTS: The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of an hCG H48/H0 ratio increase <11% to diagnose an early pregnancy loss were 70.6%, 100%, 100% and 85.3%, respectively. The sensitivity, specificity, PPV and NPV of a 6.2ng/ml progesterone level to diagnose an early pregnancy loss were 20%, 100%, 100% and 65.2%, respectively. The sensitivity, specificity, PPV and NPV of an hCG H48/H0 ratio increase >75% to diagnose a viable pregnancy were 100%, 31%, 45.9% and 100%, respectively. hCG H48/H0 ratio increase <11% was associated with early pregnancy loss in 100% of the cases. hCG H48/H0 ratio increase >75% was associated with 100% of viable pregnancies in 100% of the cases. CONCLUSION: Serial hCG levels alone permitted an early viability diagnosis within 48h for 41.1% of patients with PUV instead of 7 to 14days with TVS.
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Aborto Espontáneo/diagnóstico , Gonadotropina Coriónica/sangre , Progesterona/sangre , Aborto Espontáneo/sangre , Adulto , Largo Cráneo-Cadera , Femenino , Saco Gestacional , Humanos , Valor Predictivo de las Pruebas , Embarazo , Resultado del Embarazo , Estudios Prospectivos , Sensibilidad y EspecificidadRESUMEN
BACKGROUND: Incomplete spontaneous abortions are defined by the intrauterine retention of the products of conception after their incomplete or partial expulsion. This condition may be managed by expectant care, medical treatment or surgery. Vacuum aspiration is currently the standard surgical treatment in most centers. However, operative hysteroscopy has the advantage over vacuum aspiration of allowing the direct visualization of the retained conception product, facilitating its elective removal while limiting surgical complications. Inadequately powered retrospective studies reported subsequent fertility to be higher in patients treated by operative hysteroscopy than in those treated by vacuum aspiration. These data require confirmation in a randomized controlled trial comparing fertility rates between women undergoing hysteroscopy and those undergoing vacuum aspiration for incomplete spontaneous abortion. METHODS: After providing written informed consent, 572 women with incomplete spontaneous abortion recruited from 15 centers across France will undergo randomization by a centralized computer system for treatment by either vacuum aspiration or operative hysteroscopy. Patients will not be informed of the type of treatment that they receive and will be cared for during their hospital stay in accordance with standard practices at each center. The patients will be monitored for pregnancy or adverse effects by a telephone conversation or questionnaire sent by e-mail or post over a period of two years. In cases of complications, failure of the intervention or diagnosis of uterine cavity disease, patient care will be left to the discretion of the medical center team. DISCUSSION: If our hypothesis is confirmed, this study will provide evidence that the use of operative hysteroscopy can increase the number of pregnancies continuing beyond 22 weeks of gestation in the two-year period following incomplete spontaneous abortion without increasing the incidence of morbidity and peri- and postoperative complications. The standard surgical treatment of this condition would thus be modified. This study would therefore have a large effect on the surgical management of incomplete spontaneous abortion. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02201732 ; registered on 17 July 2014.
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Aborto Incompleto/cirugía , Aborto Inducido/métodos , Fertilidad , Histeroscopía , Legrado por Aspiración , Aborto Incompleto/diagnóstico , Aborto Inducido/efectos adversos , Adolescente , Adulto , Protocolos Clínicos , Femenino , Francia , Humanos , Histeroscopía/efectos adversos , Embarazo , Proyectos de Investigación , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del Tratamiento , Legrado por Aspiración/efectos adversos , Adulto JovenRESUMEN
OBJECTIVES: The incidence of neonatal respiratory morbidity following an elective caesarean section is 2-3 times higher than after a vaginal delivery. The microviscosity of surfactant phospholipids, as measured with fluorescence polarisation, is linked with the functional characteristics of fetal surfactant and thus fetal lung maturity, but so far this point has received little attention in newborns at term. The aim of the study is to evaluate the correlation between neonatal respiratory morbidity and amniotic microviscosity (Fluorescence Polarisation Index) in women undergoing caesarean section after 37 weeks' gestation. STUDY DESIGN: The files of 136 women who had undergone amniotic microviscosity studies during elective caesarean deliveries at term were anonymised. Amniotic fluid immaturity (AFI) was defined as a Fluorescence Polarisation Index higher than 0.335. RESULTS: Respiratory morbidity was observed in 10 babies (7.3%) and was independently associated with AFI (OR: 6.11 [95% CI, 1.20-31.1] with p=0.029) and maternal body mass index (OR: 1.12 [95% CI, 1.02-1.22] with p=0.019). Gestational age at the time of caesarean delivery was inversely associated with AFI (odds ratio, 0.46 [95% confidence interval, 0.29-0.71], p<0.001), especially before 39 weeks, and female gender was associated with an increased risk (odds ratio, 3.29 [95% confidence interval, 1.48-7.31], p=0.004). CONCLUSIONS: AFI assessed by amniotic microviscosity was significantly associated with respiratory morbidity and independently correlated with shorter gestational age especially before 39 weeks. This finding provides a physiological rationale for recommending delaying elective caesarean section delivery until 39 weeks of gestation to decrease the risk for respiratory morbidity.
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Líquido Amniótico/química , Cesárea/efectos adversos , Fosfolípidos/química , Síndrome de Dificultad Respiratoria del Recién Nacido/etiología , Adolescente , Adulto , Femenino , Polarización de Fluorescencia , Humanos , Recién Nacido , Masculino , Persona de Mediana Edad , Embarazo , Estudios Prospectivos , Estudios Retrospectivos , Viscosidad , Adulto JovenRESUMEN
OBJECTIVE: To estimate maternal outcome after conservative management of placenta accreta. METHODS: This retrospective multicenter study sought to include all women treated conservatively for placenta accreta in tertiary university hospital centers in France from 1993 to 2007. Conservative management was defined by the obstetrician's decision to leave the placenta in situ, partially or totally, with no attempt to remove it forcibly. The primary outcome was success of conservative treatment, defined by uterine preservation. The secondary outcome was a composite measure of severe maternal morbidity including sepsis, septic shock, peritonitis, uterine necrosis, fistula, injury to adjacent organs, acute pulmonary edema, acute renal failure, deep vein thrombophlebitis or pulmonary embolism, or death. RESULTS: Of the 40 university hospitals that agreed to participate in this study, 25 institutions had used conservative treatment at least once (range 1-46) and had treated a total of 167 women. Conservative treatment was successful for 131 of the women (78.4%, 95% confidence interval [CI] 71.4-84.4%); of the remaining 36 women, 18 had primary hysterectomy and 18 had delayed hysterectomy (10.8% each, 95% CI 6.5-16.5%). Severe maternal morbidity occurred in 10 cases (6.0%, 95% CI 2.9-10.7%). One woman died of myelosuppression and nephrotoxicity related to intraumbilical methotrexate administration. Spontaneous placental resorption occurred in 87 of 116 cases (75.0%, 95% CI 66.1-82.6%), with a median delay from delivery of 13.5 weeks (range 4-60 weeks). CONCLUSION: Conservative treatment for placenta accreta can help women avoid hysterectomy and involves a low rate of severe maternal morbidity in centers with adequate equipment and resources.